FDA Removes Clinical Hold on BioCryst's BCX 4161 -8K; Pacira Announces EXPAREL Phase 3 Trial Does Not Meet Primary Endpoint Print E-mail
By Staff and Wire Reports   
Thursday, 01 August 2013 19:34

Below is a look at some of the headlines for companies that made news in the healthcare sector on August 1, 2013. BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) was notified by the United States Food and Drug Administration (“FDA”) that the Clinical Hold placed on its hereditary angioedema drug BCX 4161 has been removed.

The FDA notified BioCryst that the Complete Response submitted by BioCryst to address the Clinical Hold satisfactorily addressed the FDA's concerns. This notification by the FDA provides BioCryst the ability to initiate BCX 4161 clinical trials in the United States and/or include U.S. clinical sites in its BCX 4161 clinical trials.


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Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX)
announced results from its second pivotal, Phase 3 clinical trial assessing the safety and efficacy of EXPAREL^® (bupivacaine liposome injectable suspension) in intercostal nerve block for posterolateral thoracotomy. The study did not achieve its primary endpoint of a reduction of cumulative pain scores over 72 hours.

The 180 patients in this randomized, double-blind study across the U.S., Bulgaria, Georgia, Poland and the Czech Republic received either 266 mg of EXPAREL or placebo. Patients recruited in Bulgaria and Georgia demonstrated a response favoring EXPAREL over placebo, but this response was less pronounced in patients in Poland and missing in patients recruited in the Czech Republic (there were too few U.S. patients in the study to be meaningful). The complete data set from the trial will be available in the next few weeks, and further analyses are currently underway to better understand why patients in some countries had positive results while others had a very high placebo response.

In May 2013, Pacira reported positive findings from the Phase 2 portion of its other pivotal nerve block trial, a femoral nerve block study for total knee arthroplasty; the Phase 3 portion of this study is ongoing. The U.S. Food and Drug Administration (FDA) indicated to the company at its End-of-Phase 2 Meeting that a single pivotal trial meeting its primary endpoint would be sufficient to gain approval for the nerve block indication, assuming demonstration of adequate safety. Pacira plans to submit data from the ongoing femoral nerve block study to demonstrate efficacy and safety, as well as safety data from the intercostal nerve block study, for a supplemental New Drug Application (sNDA) anticipated in early 2014.


Also Thursday:

Air Methods Corporation (Nasdaq:AIRM) will report financial results for the second quarter ended June 30, 2013 after the close of the market on Thursday, August 8, 2013.

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA)
today announced the promotion of Kelly Seither to the newly created position of Vice President, Global Strategic Marketing and New Product Planning, and Tatjana Naranda, PhD, to the newly created position of Vice President, Business Development and Global Alliance Management.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
today provided a corporate update and reported financial results for the second quarter ended June 30, 2013.

BioRestorative Therapies, Inc. (OTC BB: BRTX)
, a life sciences company focused on stem cell-based therapeutics, today announced the issuance of a shareholder letter by Chief Executive Officer, Mark Weinreb, providing an update to shareholders on the Company's progress.

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX®in the EU, announced today that it will host a conference call and live audio webcast at 8:30 a.m. EDT on Thursday, August 8, 2013 to report its second quarter 2013 financial results and provide a corporate update.

BrainStorm Cell Therapeutics (OTCQB: BCLI)
, a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it has submitted a favorable safety report to the hospital Helsinki Committee (IRB) for the second group of patients in its ongoing Phase IIa ALS clinical trial at the Hadassah Medical Center in Jerusalem, Israel.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
today announced that its second quarter 2013 financial results will be released on Thursday, August 8, 2013.

ChemoCentryx, Inc. (Nasdaq:CCXI)
announced today that the Company's second quarter 2013 financial results will be released after market close on Monday, August 12, 2013. ChemoCentryx executive management will host a conference call beginning at 5:00 p.m. Eastern Time on August 12, 2013, to discuss these results and to answer questions.

Digirad Corporation (NASDAQ: DRAD)
announced today that it has signed an agreement to sell its "Trapper" Surgical Imaging Technology previously under development, as well as license "Trapper" related technology to Novadaq Technologies, a publicly-traded developer of clinically-relevant imaging solutions for use in surgical and outpatient wound care procedures.

Digirad Corporation (NASDAQ: DRAD)
today reported revenue of $12.9 million for the second quarter, a narrowing loss and an ending cash, cash equivalents and available-for-sale securities balance of $22.2 million.

Diversicare Healthcare Services, Inc. (Nasdaq:DVCR)
today announced multiple pending transactions as part of its portfolio management strategy.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, announced today that Shelley Thunen, Chief Financial Officer, is scheduled to present at the Canaccord Genuity 33rd Annual Growth Conference in Boston, MA.

Endocyte, Inc. (Nasdaq:ECYT)
, a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy in cancer and other serious diseases, today announced financial results for the second quarter ending June 30, 2013, and provided a business update.

FEI (Nasdaq:FEIC) today introduced three new systems that tailor the power of transmission electron microscopy (TEM) to specific application and industry needs.

Halozyme Therapeutics, Inc. (NASDAQ: HALO)
announced that following discussions with the Center for Biologics Evaluation and Research (CBER) division of the U.S. Food and Drug Administration, ViroPharma will be discontinuing their Phase 2 study of subcutaneous Cinryze (C1 Esterase Inhibitor [Human]) with recombinant human hyaluronidase (rHuPH20).

Life Technologies Corporation (NASDAQ: LIFE)
today announced the launch of its first state-of-the-art forensics laboratory.

Novadaq® Technologies Inc. (NASDAQ:NVDQ) (TSX:NDQ)
, a developer of clinically-relevant imaging solutions for use in surgical and outpatient wound care procedures, today announced that it has acquired all assets relating primarily to the "Trapper" Surgical Imaging technology, and the Disposable Probe, previously in development by Digirad Corporation (NASDAQ:DRAD).

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ)
, a developer of clinically-relevant fluorescence imaging solutions for use in surgical and outpatient wound care procedures, today announced financial results for its second quarter ended June 30, 2013.

Omeros Corporation (NASDAQ: OMER)
announced that the company recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for approval of OMS302 for use in patients undergoing intraocular lens replacement (ILR) surgery.

Pacific Biosciences of California, Inc. (Nasdaq:PACB)
today announced financial results for the second quarter ended June 30, 2013.

PDL BioPharma, Inc. (NASDAQ: PDLI)
today announced that the Company will release its second quarter 2013 financial results for the period ended June 30, 2013, on Thursday, August 8, 2013, after market close.

Regenerative medicine Company Avita Medical Ltd. (ASX: AVH) (PINKSHEETS: AVMXF) (OTCQX: AVMXY) announced the initial enrollment of three patients in the RESTORE trial, a multi-centre, randomized European clinical trial evaluating the use of ReCell® Spray-on Skin® in the management of patients with venous leg ulcers.

Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported financial results for the second quarter of 2013.

Senomyx, Inc. (NASDAQ: SNMX)
, a company using proprietary taste science technologies to discover, develop, and commercialize novel flavor ingredients for the food, beverage, and ingredient supply industries, today reported financial results for the second quarter 2013.

Sorrento Therapeutics, Inc. (OTCQB: SRNE)
announced today that it has filed a Certificate of Amendment to its Restated Certificate of Incorporation to effect a 1-for-25 reverse stock split of its common stock, effective on July 30, 2013.

Symmetry Technologies Inc. (OTC:SMMR)
is pleased to announce that it has licensed a Human Rejuvenation Nutraceutical product for retail sale from a US based FDA compliant laboratory that it will sell under the brand name "Resurgencell".

Tikcro Technologies Ltd. (OTC PK: TIKRF)
today reported results the second quarter ended June 30, 2013.

TG Therapeutics, Inc. (Nasdaq:TGTX)
, an innovative clinical-stage biopharmaceutical company focused on the acquisition, development, and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs, today announced its results for the second quarter ended June 30, 2013 and recent company developments.

VIROPHARMA INCORPORATED (Nasdaq: VPHM)
today announced financial results for the second quarter of 2013. Net sales were $104 million for the second quarter ended June 30, 2013 as compared to $95 million in the comparative period of 2012.




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